September 2021 Office of Women's Health e-Update
Message from the Associate Commissioner
Dear Women’s Health Colleagues,
The fall season is a busy one for many of us with children as we strive to manage back-to-school responsibilities. We understand that parents have questions about the COVID-19 vaccine and when it will be available for children under the age of 12. Therefore, we are sharing a recent consumer update from FDA outlining steps the Agency will take to ensure the safety and efficacy of these products for children. We encourage you to read the update to learn how the FDA Will Follow The Science On COVID-19 Vaccines For Young Children.
This week marks the beginning of National Hispanic Heritage Month. Our Office has developed numerous Spanish language health education resources, as well as a toolkit from the agency, aimed at informing women about diabetes, heart disease, menopause, and more. I invite you to download or order our free health education publications for yourself and please share them with all the women in your community.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
Below are links to specific COVID-19 topics and the latest vaccine fact sheets, with a full list of the latest COVID-19 information from the FDA here.
- FDA In Brief: FDA to Hold Advisory Committee Meeting to Discuss Pfizer-BioNTech’s Application for COVID-19 Booster
- FDA Approves First COVID-19 Vaccine
- Your Coronavirus Q&As for Consumers from FDA
- Why You Should Not Use Ivermectin to Treat or Prevent COVID-19
CALL TO ACTION
September is Healthy Aging Month, an annual health observance dedicated to promoting the positive features of aging. As we get older, it is important that we develop and continue to maintain healthy lifestyle choices. This month, we empower older women to improve their overall health and well-being by prioritizing physical wellness, and a healthy mental and social state. Check out some healthy aging tips here.
WOMEN'S HEALTH HIGHLIGHTS
FDA Will Follow The Science On COVID-19 Vaccines For Young Children
As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are anxious about the pandemic and protecting their children. Many parents have questions about COVID-19 and when vaccines will be available for children younger than 12 years of age.
FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted
The following is attributed to Acting FDA Commissioner Janet Woodcock, M.D., and Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products
On this day last year, the U.S. Food and Drug Administration faced the unprecedented task of reviewing applications for over 6.5 million “deemed” new tobacco products – many of which were already on the market. A majority of the applications submitted by a court-ordered deadline of Sept. 9, 2020, were for electronic nicotine delivery systems (ENDS) products, such as e-cigarettes and e-liquids, which had never been through the FDA review process.
FDA, FTC Warn 10 Companies Illegally Selling Dietary Supplements Claiming to Treat Diabetes
The U.S. Food and Drug Administration and the Federal Trade Commission posted warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent diabetes, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA is urging consumers not to use these or similar products because they have not been evaluated by the FDA to be safe or effective for their intended use and may be harmful.
FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
Based on a completed FDA review of a large, randomized safety clinical trial, we have concluded there is an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). This trial compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz. A prior DSC based upon earlier results from this trial, reported an increased risk of blood clots and death only seen at the higher dose.
FDA Approves First-of-Its-Kind Stroke Rehabilitation System
FDA approved the MicroTransponder Vivistim Paired VNS System (Vivistim System), a first-of-its-kind, drug-free rehabilitation system intended to treat moderate to severe upper extremity motor deficits associated with chronic ischemic stroke—a stroke caused by a blockage of blood flow to the brain with long-lasting symptoms—using vagus nerve stimulation (VNS).
Lupus Therapies Continue to Evolve
It can be a difficult disease to diagnose and a difficult disease to treat. It’s called lupus, and as many as 24,000 people in the United States are diagnosed with the disease each year. Scientists today are working on many fronts to understand the genetic underpinnings of the disease and to develop new and more targeted therapies to treat it.
FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health
FDA issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products after determining the applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. The products from JD Nova Group LLC, Great American Vapes, and Vapor Salon subject to this action are non-tobacco-flavored ENDS and they include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.
FDA Releases PFAS Testing Results from First Survey of Nationally Distributed Processed Foods
The U.S. Food and Drug Administration released the results of the first survey of per- and polyfluoroalkyl substances (PFAS) in nationally distributed processed foods, including several processed baby foods, collected from the agency’s Total Diet Study (TDS), which monitors levels of nutrients and contaminants in foods consumed in the U.S. PFAS are chemicals found in a number of consumer and industrial products because of their resistance to grease, oil, water and heat.
Mammography Problems at Madison Avenue Radiology Center 190th Broadway in New York, NY - FDA Safety Communication
FDA is alerting patients who had mammograms at Madison Avenue Radiology Center, 190th Broadway in New York, NY, on or after February 26, 2019, about possible problems with the quality of their mammograms.
UPDATE: Caution When Using Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication
FDA issued a safety communication to remind patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In addition, the FDA is aware of allegations that clinical studies are being conducted using RAS devices to perform mastectomies for the prevention or treatment of cancer without the FDA oversight required for such significant risk studies.
BlackBerry QNX Cybersecurity Vulnerabilities May Affect Certain Medical Devices
FDA is notifying patients, health care providers, and manufacturers about cybersecurity vulnerabilities with a “real-time operating system (RTOS)” designed by QNX and owned by BlackBerry. These vulnerabilities may introduce risks for certain medical devices. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. Manufacturers are assessing which devices may be affected by the BlackBerry QNX cybersecurity vulnerabilities and are evaluating the risk and developing mitigations, including deploying patches from BlackBerry.
Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX® (varenicline) Tablets Due to N- Nitroso Varenicline Content
Pfizer is recalling an additional four lots of Chantix 0.5mg/1 mg due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.
Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication. The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
Pregnancy exposure registries are studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy.
Learn more about pregnancy registries today!
Participate in Upcoming FDA Meetings
- Workshop on Bioactive Ingredients in Infant Formula, September 23-24, 2021
- FDA In Brief: FDA Announces Public Workshop to Reconsider Mandatory Prescriber Education for Opioids
- FDA In Brief: As Consumers Order More Meals and Groceries Online, FDA Plans Public Meeting to Address Food Safety Risks
- New Era of Smarter Food Safety Summit on E-Commerce: Ensuring the Safety of Foods Ordered Online and Delivered Directly to Consumers, October 19-21, 2021
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.